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Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR System, laptop
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Catalog No. A47326
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The Applied Biosystems QuantStudio 5 Dx Real-Time PCR System is an in vitro diagnostic (IVD) quantitative PCR system that delivers proven performance and support to help meet the needs of clinical/hospital laboratories and test developers, in a compact footprint and cost-effective package.

The Applied Biosystems QuantStudio 5 Dx Real-Time PCR System is an in vitro diagnostic (IVD) quantitative PCR system that delivers proven performance and support to help meet the needs of clinical/hospital laboratories and test developers, in a compact footprint and cost-effective package. This system is both US-IVD and CE-IVD, IVDR compliant. 

Flexibility and security
The QuantStudio 5 Dx software is a combined-function software that enables both Development (DEV) and In Vitro Diagnostic (IVD) operation as discrete operating modes, minimizing risk of operation in the incorrect instance.

The software enables you to maintain secure access to the instrument, specify user access to various software functions, record all actions completed by users, and sign data electronically by virtue of Security, Auditing, and E-signature features.

This QuantStudio 5 Dx system is offered in a 96-well, 0.2 mL configuration and accommodates reaction volumes from 10 to 100 uL, as well as both standard and fast chemistries to meet varying user demands.

Trusted performance
Resulting from over 20 years of real-time PCR experience, the QuantStudio 5 Dx system includes proven Applied Biosystems OptiFlex technology and VeriFlex blocks for enhanced data quality. By enabling de-coupling of excitation and emission filters with OptiFlex technology, users may optimize performance for specific dyes and when multiplexing. With VeriFlex blocks, users may precisely set the temperature on six independently-controlled thermal zones across the 96-well sample block for optimal PCR amplification performance.

Cost effective
The QuantStudio 5 Dx system is our most affordable IVD qPCR platform. It is factory-calibrated and, following installation qualification and operational qualification by a factory-certified engineer, ready for operation by trained users. Subsequent IVD dye calibrations are now user-enabled for convenience and to minimize ongoing operating costs.

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Specifications

Block Format Non-interchangeable
Format 96-well, 0.2 mL
Content And Storage • 1 QuantStudio 5 Dx 0.2 mL 96-well instrument
• 1 Dell laptop computer
• 1 QuantStudio 5 Dx IVD software kit
• 1 QuantStudio 5 Dx IVD user documentation kit
• 1 Installation and qualification service

Dimensions 40 x 27 x 50 cm (H x W x D)
Product Line QuantStudio
Shipping Condition Room Temperature
Quantity 1 system
Weight 27 kg
What is the difference between continuous melt curves and step and hold melt curves on the Applied Biosystems Real-Time PCR Instruments?

Continuous melt curve: increases the temperature by the ramp increment (degrees C/sec) so that the temperature will change at a constant rate set in the protocol.
Step and Hold melt curve: increases the temperature by the ramp increment (degrees C) and then holds at that temperature for the time specified by the user.

The amount of data collected will depend on the filter(s) selected. The more filters you use, the longer the acquisition will take and the fewer data points will be collected.

Can I start a run on the QuantStudio 5 Dx with the Development Software if the instrument calibrations are expired?

No. You cannot start a run on this instrument if calibrations are expired.

What is the admin pin for QuantStudio 3 and 5 Real-Time PCR Systems?

If the admin PIN has not been changed, 1234 should work. If it does not work, you can also try 0000.
However, if the admin PIN has been changed and none of the above PINs work, follow the instructions in the QuantStudio 3 and 5 Real-Time PCR Systems manual, page 100.

How do I download the Pathogen Interpretive Software?

Once you place your order, please contact our Instrument Service team at 1-800-955-6288 option 3, 1 (this kit is only available in North America). You will be given an access code to the TaqPath Monkeypox/Orthopox Virus DNA Kit eLearning where you’ll learn how to install, update, and download the Pathogen Interpretive Software package for the TaqPath Monkeypox/Orthopox Virus DNA Kit.

With the TaqPath Monkeypox/Orthopox Virus DNA Kit, what software should I use for data analysis?

Results are analyzed using the following software:
- Applied Biosystems Pathogen Interpretive Software v1.1
- SAE Administrator Console Dx v1.0 or v1.2 (for security and audit functions)
- Pathogen Interpretive Software 1.0.0 DAT (SAE Profile)

Please use the appropriate assay panel and template for your instrument:
- MPXOPX-EUA_QS5-9601_1.0.0.zip
- MPXOPX-EUA_QS5Dx-9602_1.0.0.zip
- MPXOPX-EUA_QS7F-384_1.0.0.zip

Note: These zip files are located in EducationConnect (www.thermofisher.com/educationconnect). The eLearning course needs to be completed to be granted access.

What is the instrument software configuration required to use the TaqPath Monkeypox/Orthopox Virus DNA Kit?

To obtain the correct analysis software or firmware version for your real-time PCR instrument, go to thermofisher.com/validatedfirmware, then select your instrument in the Real-Time PCR section.

Which instruments are authorized under the EUA for use with the TaqPath Monkeypox/Orthopox Virus DNA Kit?

Here are the instruments that can be used with the TaqPath Monkeypox/Orthopox Virus DNA Kit:
- Applied Biosystems QuantStudio 5 Real-Time PCR System (96-well, 0.1 mL block)
- Applied Biosystems QuantStudio 5 Dx Real-Time PCR System (96-well, 0.2 mL block)
- Applied Biosystems QuantStudio 7 Flex Real-Time PCR System (384-well block)

I would like to use the TaqPath Monkeypox/Orthopox Virus DNA Kit. Which extraction kit should I use to extract DNA from the sample?

Performance was established using the MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit (Cat. No. A48383) in combination with the KingFisher Flex Magnetic Particle Processor with 96 Deep-Well Head and the KingFisher Flex 96 Deep-Well Heating Block (MVP_2Wash_400_Flex program). Other purification methods may lead to deviations in the expected result.

Which specimen types are compatible with the TaqPath Monkeypox/Orthopox Virus DNA Kit?

The TaqPath Monkeypox/Orthopox Virus DNA Kit protocol is currently authorized for use with lesion swab specimens in universal transport media (UTM) or viral transport media (VTM) from individuals suspected of monkeypox infection by their healthcare provider.

What instruments, consumables, and reagents do I need for the TaqPath Monkeypox/Orthopox Virus DNA Kit? Where can I find the full list of EUA products and protocols?

Go to www.thermofisher.com/monkeypox and download the Instructions for Use (IFU) to see the workflow outlining the instruments, consumables, and reagents required to run Monkeypox detection experiments.

What are the reporter dyes and targets for the TaqPath Monkeypox/Orthopox Virus DNA Kit?

The reporter dyes used are as follows:
- Monkeypox virus: FAM dye
- Orthopoxvirus: VIC dye
- RNase P: JUN dye

The TaqPath Monkeypox/Orthopox Virus DNA Kit probes contain QSY and MGB quenchers, which do not fluoresce. Select None for Quencher in the instrument set up procedure.

What are the components of the TaqPath Monkeypox/Orthopox Virus DNA Kit? Is the master mix included, or does it need to be purchased separately? Are there any other required materials that are not supplied?

The TaqPath Monkeypox/Orthopox Virus DNA Kit includes the following components:
- TaqPath Monkeypox/Orthopox Virus Multiplex Assay: Multiplexed real-time PCR assay containing primers/probes specific to monkeypox virus, non-variola orthopoxvirus targets, and human RNase P.
- TaqPath Monkeypox/Orthopox Virus DNA Positive Control: Positive DNA control that contains templates specific to monkeypox virus, non-variola orthopoxvirus targets, and human RNase P regions targeted by the assay.

Note:
- The master mix is not included in the kit and needs to be purchased separately: TaqPath BactoPure Microbial Detection Master Mix (No ROX) (Cat. No. A52703, A52704, or A52705)
- TE Buffer (Cat. No. 12090015) and Nuclease-free water (MLS) are required and not supplied with the kit.


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